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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Multicolor Fluorescent Imaging Cytometric Analysis System
510(k) Number K150815
Device Name BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
Applicant
Becton, Dickinson and Company
2350 Qume Dr.
San Jose,  CA  95131
Applicant Contact Catherine(Katie) Bessette
Correspondent
Becton, Dickinson and Company
2350 Qume Dr.
San Jose,  CA  95131
Correspondent Contact Catherine(Katie) Bessette
Regulation Number864.5220
Classification Product Code
PMG  
Subsequent Product Codes
GKL   JPK   OYE  
Date Received03/27/2015
Decision Date 12/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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